Important news for pharma companies: the Bolar exemption is about to be broadened

Before a medicinal product can be marketed in the UK, it must first be given regulatory approval following clinical tests to show that the product is safe and effective. Producers of generic medicines can use the original manufacturer’s approval provided they can show that the generic product is bioequivalent to the approved medicine. However, the generic producer may face an action for patent infringement if it conducts clinical trials on a patented product before the expiry of the patent. The Bolar exemption means that such clinical trials will not constitute patent infringement.

The exemption sits within two EU directives — the directive on medicinal products for human use and a directive on veterinary medicinal products — and the relevant provisions are transposed into English law by section 60(5) of the Patents Act 1977.

The government has been consulting on broadening the scope of the Bolar exemption and, to that end, the draft Legislative Reform (Patents) Order 2014 was laid before Parliament on 6 May 2014. Broadly, the draft order will extend the Bolar exemption to cover the conducting of necessary trials and health technology assessments of all drugs, both novel and generic, and all applications for marketing authorisations…

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